Non-invasive Glioma Characterization Through Molecular Imaging

Not Applicable

Recruiting

• Conditions: Glioma; Primary Brain Tumor; Malignant Primary Brain Tumor; Brain Tumor; Malignant Glioma

• Registration Number: NCT03684109
• Lead Sponsor: University of Miami

Brief Summary

MRI-based sequences can provide non-invasive quantification of intratumoral 2-hydroxyglutarate (2HG) distribution and tumor cellularity in human gliomas and help guide the development of novel glioma therapies.

Detailed Description

This is a pilot study aiming at developing and optimizing MRI-based sequences to provide non-invasive quantification of intratumoral 2-hydroxyglutarate (2HG) distribution and tumor cellularity in human gliomas and help guide the development of novel glioma therapies.

Study Timeline

• Study First Submitted: 2018-09-21
• Study First Submitted QC: 2018-09-21
• Study First Posted: 2018-09-25
• Study Start: 2019-01-25
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-28
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Adults (≥18 year old)
• Subjects with suspected or confirmed gliomas and who will have a medically indicated biopsy or resection of his/her brain lesion.

Exclusion Criteria

• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Patients unable to have MRI done

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
2HG Concentration via 3T MRI Scanner	Day 1	2HG concentrations as measured via 3T MRI Scanner.
2HG Concentration from tissue samples	Day 1	2HG concentrations as measured via patient's surgically excised tissue sample ex vivo by tissue based liquid chromatography-mass spectrometry (LC-MS)

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States